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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011329
Receipt No. R000013268
Scientific Title Outcomes and risk stratification after endovascular therapy for patients with PAD
Date of disclosure of the study information 2013/08/01
Last modified on 2013/09/04

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Basic information
Public title Outcomes and risk stratification after endovascular therapy for patients with PAD
Acronym OPEN-PAD trial
Scientific Title Outcomes and risk stratification after endovascular therapy for patients with PAD
Scientific Title:Acronym OPEN-PAD trial
Region
Japan

Condition
Condition PAD
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate clinical outcome and risk factor of PAD patient with EVT.
Basic objectives2 Others
Basic objectives -Others To evaluate changing of QOL in PAD patient with EVT.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes all cause death
non fatal myocardiac infarction
stroke
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria PAD patient recommended endo vascular therapy.
over 20 years old.
not exclusion criteria patient.
patient with consent of EVT.
Key exclusion criteria patient unavailable of anti platelet agents and anticoagulant.
Allergy of contrast agents.
Life expectancy 12 months.
During pregnancy and suckling.
inappropriate patient determined from study director.
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhisa Hagiwara
Organization Tokyo Women's medical university
Division name cardiology
Zip code
Address 8-1, kawada-cho, shinjuku-ku, tokyo
TEL 03-3353-8111
Email nakaomasashi@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Nakao
Organization Tokyo Women's medical university
Division name cardiology
Zip code
Address 8-1, kawada-cho, shinjuku-ku, tokyo
TEL 03-3353-8111
Homepage URL
Email nakaomasashi@gmail.com

Sponsor
Institute Tokyo Women's medical university
department of cardiology
Institute
Department

Funding Source
Organization non
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2017 Year 07 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information MACE, MACLE, cause of death, major or minor amputation, QOL score etc

Management information
Registered date
2013 Year 07 Month 31 Day
Last modified on
2013 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013268

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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